Effectiveness of Self-cross-linked Hyaluronic Acid Gel in the Prevention of Intrauterine Adhesions After Second Trimester Abortion
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 主要终点
- The presence of de-novo post-curettage adhesions
研究概览
简要总结
This prospective, randomized, controlled study evaluates the efficacy of self-crosslinked hyaluronic acid gel to prevent the development of de-novo intrauterine adhesions following curettage for retained product after second trimester abortion. One group of participants will underwent curettage plus intrauterine application of self-crosslinked hyaluronic acid gel while the other group will underwent curettage alone (control group).
详细描述
Intrauterine adhesions are the major long-term complication of curettage for retained products of conception. The risk of adhesion is higher after second trimester abortion. This complication may result in infertility, recurrent miscarriages and irregular periods with dysmenorrhea and pelvic pain.
They have been reported that the intrauterine application of auto-crosslinked hyaluronic acid gel following hysteroscopic adhesiolysis or hysteroscopic surgery significantly reduces the formation of post-operative intrauterine adhesions.
The aim of this prospective, randomized, controlled study is to evaluate the efficacy of self-crosslinked hyaluronic acid gel in the reduction of development of de-novo post-curettage adhesions at 2 months follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject has curettage for retained product after second trimester abortion
排除标准
- •History of curettage or other intrauterine surgery
- •History of post-abortion complication or infection
结局指标
主要结局
The presence of de-novo post-curettage adhesions
时间窗: 2 months
In 2 months following the curettage, Hysteroscopy will perform to observe of whether there is any intrauterine adhesion
次要结局
- The characteristic of the intrauterine adhesions(2 months)
研究者
Ozlem Dural
M.D., Principal Investigator
Istanbul University